The 28 healthy adult volunteers in the study were co-administered with pitavastatin and darunavir/ritonavir over a 16-day period, The study showed no clinically significant change in blood levels for pitavastatin or protease inhibitor combination darunavir/ritonavir .
When co-administered with darunavir/ritonavir, pitavastatin peak exposure, as measured by Cmax, decreased by 4%, while total exposure of pitavastatin, as measured by AUC0-t, decreased by approximately 26%.
When co-administered with pitavastatin, the Cmax and AUC0-t of darunavir increased by 6% and 3% respectively, and the Cmax and AUC0-t of ritonavir increased by 2% and 8%, respectively, the study reported.
Kowa Pharmaceuticals America medical affairs vice president Craig Sponseller said, "Examining drug interactions has been an ongoing part of product development, and we are pleased that results show no clinically significant drug interaction between pitavastatin and the protease inhibitor combination darunavir/ritonavir."
The evaluation of the safety of pitavastatin and darunavir/ritonavir when each treatment was given alone or in combination was the secondary objective of the study.
According to the company, the majority of treatment emergent adverse events (TEAEs) were mild in severity, and no serious or severe adverse events were reported.